University of Kentucky Phase 1 trial of CBD oil For PCa BCR. Estimated study completion time September 2021.

[Graham49]

A phase I, dose-expansion cohort study on the safety of a cannabidiol for biochemical recurrence in prostate cancer patients.

Zin Myint, William H. St Clair, Stephen Strup, Peng Wang, Andrew Callaway James, Donglin Yan, ...

Abstract

TPS263

Background: Cannabinoids, widely used in pain control, as an appetite stimulant, and anti-emetic in cancer patients, may play role as an anti-carcinogenic agent. A preclinical study demonstrated that cannabinoid receptors (CB1 and CB2) were highly expressed in human androgen-responsive prostate cancer (PCa) cells (LNCaP) as compared to normal prostate epithelial cells (PrEC). When these two cell lines were treated with a potent cannabinoid receptor agonist, PCa cells showed a decrease in prostate-specific antigen (PSA) protein expression and increased apoptosis in a dose and time-dependent manner with no effect seen in PrEC cells. An FDA-approved cannabidiol (CBD) agent, is derived from Cannabis sativa L. plants. Extracts from these plants are processed to yield pure CBD and contain less than 0.5% THC. We will expand these preclinical studies with a phase I trial. Methods: This trial is an open-label, single-center, phase I dose escalation study followed by dose expansion to evaluate acute toxicity, long-term safety and tolerability, and preliminary antitumor activity of cannabidiols in patients with biochemically recurrent (BCR) PC after primary definitive local therapy and prostate-specific antigen doubling time ≤ 12 months. The dose escalation will be determined by a Bayesian Optimal Interval design and the target dose-limiting toxicity rate is set at 30%. An additional 6-9 patients will be enrolled as an expansion cohort once the maximum tolerated dose is determined. Patients will be treated for a total 90 days with a 10 day taper. The primary objective is to evaluate the acute toxicity and long-term safety and tolerability of cannabidiols in patients with BCR. The secondary objective includes measuring changes in serial PSA levels, PSA velocity, and testosterone levels and to assess health-related quality of life (EORTC QLQ-C30 and QLQ-PR 25) from baseline throughout the treatment period. CB receptor 1 and 2 expression levels by immunohistochemistry staining will be evaluated from archival prostatectomy specimens if available as an exploratory objective. This trial opened on 7.28.2020 and has started enrollment. Clinical trial information: NCT04428203.

© 2021 by American Society of Clinical Oncology

Research Sponsor:

Cancer Center Support Grant (CCSG).

[Shooter1]

Only 3 mo. trial with lots of exclusions.

[Graham49 in reply to Shooter1]

Yes, only a phase 1 but it's a start.

[Shooter1 in reply to Graham49]

Already using CBD for back pain on bad days. It works for pain that makes it hard to breath..

[novatimo]

On ClinicalTrials.gov it says "active, not recruiting". No contact details for researchers if one has questions?

[donits]

Thank you for this interesting post. I remember one advanced lung cancer patient taking Fenbendazole along with CBD.

[cesces]

This aught to be interesting.

Dr. Myers observed that his patients who self treated themselves with cannabis seemed to have very very noticeably higher levels of metastasis.

His hypothesis was that cannabis was promoting the growth of prostate cancer.

This isn't exactly cannabis, but it's close.

[Graham49 in reply to cesces]

Yes, it's only one of the cannabinoids, and were any of Dr Myers patients smoking the cannabis?

[cesces in reply to Graham49]

Almost certainly. That and perhaps brownies.

Just people buying it, with substantially differing constituents, off the street and proudly self medicating with it.

The effect he observed was so pronounced, that the varying quantities and compositions didn't make any difference.

There are about 175 cannabinoids. So selecting only one might make a difference.

[V10fanatic]

There's a big difference from smokin' some random strain of weed, and sublingually ingesting lab tested and highly purified CBD. I hope the participants get some beneficial results so the medical community will put much more $$ towards it's future development.